Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor (APATC)
2026年6月10日 更新者：Center Eugene Marquis
The goal of this clinical trial is to assess the feasibility of an adapted physical activity (APA) program in adult patients (≥18 years) with primary brain tumors, regardless of tumor type, grade, treatment stage, or the presence of motor, sensory, attention, concentration, or memory deficits.
The main question it aims to answer is:
What is the effective adherence rate to an APA program among eligible patients with primary brain tumors?
Additional questions include:
- What is the observance rate (number of sessions completed, intensity achieved, and duration) during the 3-month supervised APA program?
- What is the retention rate (proportion of patients completing the program and continuing APA beyond the initial period)?
- What is the impact of APA on quality of life, anxiety-depression, and cancer-related symptoms (measured via QLQ-BN20, HADS, and MFI-20 questionnaires at baseline, 3, and 4 months)?
Participants will:
- Undergo a 3-month supervised APA program (with possible continuation beyond this period).
- Use connected watches to monitor physical activity (if they accept the general conditions of use).
- Complete self-questionnaires (IPAQ, BREQ-2, QPP, QLQ-BN20, HADS, MFI-20) at inclusion, 3 months, and 4 months.
- Be followed for a total of 4 months after inclusion.
調査の概要
研究の種類
介入
入学 (推定)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Valérie JOLAINE
- 電話番号：0299253036
- メール：v.jolaine@rennes.unicancer.fr
研究場所
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-
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Rennes、フランス、35000
- Centre Eugene Marquis
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コンタクト：
- Valérie JOLAINE
- 電話番号：0299253036
- メール：v.jolaine@rennes.unicancer.fr
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主任研究者：
- Elodie VAULEON, DR
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Men or women ≥ 18 years old,
- Receiving medical oncology treatment at the CLCC Eugène Marquis,
- Diagnosed with a primary brain tumour, regardless of diagnosis, grade or treatment,
- Possible motor, sensory, attention, concentration, or memory deficits,
- Patients who accept the general terms of use for connected watches
- Patients affiliated with or covered by the French social security system,
- Patients who have received information and signed informed consent (or their legal representative),
Exclusion Criteria:
- WHO score ≥ 3
- Comprehension disorders that prevent participation in adapted physical activity
- Pregnant or breastfeeding women
- Patients without the necessary devices to use a smartwatch (smartphone, tablet or computer),
- Patients deprived of liberty, under guardianship, or curatorship, or subject to any other administrative safeguard measure.
Patients unable to comply with the study schedule for social, medical, or psychological reasons.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PA with Strength Sheets + Walking Recommendation
Patients receive 2 strength exercise sheets to perform weekly at home + a recommendation to walk regularly (30 min/day).
No supervised sessions.
Activity is self-monitored via connected watch.
|
Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
|
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実験的：APA with Strength Sheet + Group Videoconference Session
Patients receive 1 strength exercise sheet to perform weekly at home + 1 hour of group training via videoconference per week.
The videoconference session content matches the 2nd strength sheet from Arm 1. Activity is self-monitored via connected watch.
|
Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
|
|
実験的：APA with Strength Sheet + Individual Home Session
Patients receive 1 strength exercise sheet to perform weekly at home + 1 hour of individualized and personalized training at home per week.
The home session content matches the 2nd strength sheet from Arm 1. Activity is self-monitored via connected watch.
|
Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors.
It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility.
APA is supervised by trained professionals and adapted to each individual's abilities and needs.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effective adherence rate to the Adapted Physical Activity program
時間枠：Baseline to 4 months
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The primary outcome is the proportion of eligible patients who participate in at least one Adapted Physical Activity session out of the total number of eligible patients solicited for inclusion.
This metric Evaluates the feasibility of Adapted Physical Activity implementation in brain tumor patients.
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Baseline to 4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adapted Physical Activity program observance rate
時間枠：Baseline to 4 months
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Evaluated through the number of sessions completed, the number of sessions reaching the recommended intensity level, and the duration of sessions performed during the 3-month supervised period and the 1-month autonomous period.
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Baseline to 4 months
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Retention rate during the 3-month supervised Adapted Physical Activity period
時間枠：Baseline to 3 months
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Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation.
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Baseline to 3 months
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Retention Rate After Supervised Adapted Physical Activity Period
時間枠：4 months
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Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months.
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4 months
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Reasons for early discontinuation of Adapted Physical Activity
時間枠：Baseline to 4 months
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Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely
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Baseline to 4 months
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Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20
時間枠：Baseline, 3 months, and 4 months
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Evaluation of brain tumor-specific quality of life using the EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20 questionnaire, which assesses symptoms and functional domains relevant to brain tumor patients
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Baseline, 3 months, and 4 months
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Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire
時間枠：Baseline, 3 months, and 4 months
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Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress
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Baseline, 3 months, and 4 months
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Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire
時間枠：Baseline, 3 months, and 4 months
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Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire
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Baseline, 3 months, and 4 months
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Physical activity level assessment using International Physical Activity Questionnaire
時間枠：Baseline, 3 months, and 4 months
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Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels
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Baseline, 3 months, and 4 months
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Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2
時間枠：Baseline, 3 months, and 4 months
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Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2
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Baseline, 3 months, and 4 months
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Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire
時間枠：Baseline, 3 months, and 4 months
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Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire
|
Baseline, 3 months, and 4 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Elodie VAULEON, Dr、Centre de Lutte contre le Cancer Eugène Marquis
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年6月1日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。